Manufacturer registered with FDA
LuxCreo Inc.
Chicago, IL, United States. Lists 5 dental device types with FDA across 1 registered establishment, and holds 4 510(k) clearances as applicant.
- Device types listed
- 5
- Brands and models
- 6
- 510(k) clearances
- 42022–2026
- Markets registered in
- 46 registrations outside the US
- Establishments
- 1United States
510(k) clearances per year, 2007–2026
Registered in 4 markets
Where regulators' registries name LuxCreo Inc. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | LuxCreo Inc. | 4 clearances | 2022–2026 | Below |
| Canada | Health Canada | Registration holder | LUXCREO INC. | 4 | 2025–2026 | Pure Global AI |
| Australia | TGA | Manufacturer | LuxCreo Inc | 1 | 2026–2026 | Pure Global AI |
| Israel | AMAR | Manufacturer | LuxCreo Inc. | 1 | — | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What LuxCreo Inc. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Sequential AlignerNXC · Class 2 | Clear aligners | Maker | LuxCreo Clear Aligner System | 2023 |
| Orthodontic Space Preformed MaintainerDYT · Class 1 | Retainers, expanders & headgear | Maker | LuxCreo Clear Retainer SystemLuxCreo Dental Clear Aligner Resin | 2020 |
| Rebasing Repairing Relining Denture ResinEBI · Class 2 | Denture resins & teeth | Maker | FPD Reisn | 2025 |
| Shellac Base PlateEEA · Class 1 | — | Maker | LuxCreo Dental Night Guard Resin | 2021 |
| Preformed Tooth PositionerKMY · Class 1 | Retainers, expanders & headgear | Maker | LuxCreo Dental Night Guard Resin | 2024 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names LuxCreo Inc. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 23 Oct 2026 | K260421 | LuxDesign | PNN Orthodontic Software |
| 25 Nov 2025 | K253365 | LuxCreo Flexible Partial Denture Resin | EBI Rebasing Repairing Relining Denture Resin |
| 8 Apr 2025 | K250343 | LuxCreo Clear Aligner System | NXC Sequential Aligner |
| 31 May 2022 | K212680 | LuxCreo Clear Aligner System | NXC Sequential Aligner |
Some of these clearances are listed with FDA today by another company: Ningbo Sezen Technology Co., Ltd. (1).
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| LUXCREO INC.FDA reg. 3016237718 | Chicago, IL, United States | Manufacturer, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10071055). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.